Phase 1 Study of C.001 in Retinal Degeneration
Recruiting now · Phase 1
Conditions studied: Geographic Atrophy, Stargardt Disease, RPE-mediated Maculopathy, Age Related Macular Degeneration
In brief
This is a first-in-human Phase 1 study evaluating the safety and tolerability of C.001 in patients with retinal diseases involving degeneration of the retinal pigment epithelium. Participants will receive a single administration of C.001 delivered by subretinal injection. The study will evaluate three dose levels in a sequential manner. The primary objective is to assess the safety of C.001 over a 3-month period following administration. Participants will be followed for up to 12 months to further evaluate safety and explore changes in visual function and retinal structure.
Key facts
- Study ID
- NCT07594236
- Run by
- Cellio Therapeutics Inc
- People needed
- 15
- Starts
- 2026-04-07
- Expected to finish
- 2029-12-31
- Last updated by the study team
- 2026-08-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥18 years
- Diagnosis of retinal disease associated with retinal pigment epithelium degeneration (e.g., geographic atrophy or Stargardt disease)
- Visual acuity within protocol-defined limits
- Stable ocular condition prior to enrollment
- Medically suitable for ophthalmic surgery and anesthesia
- Willingness to comply with study procedures and follow-up
You may not qualify if…
- Active or prior choroidal neovascularization (CNV)
- Recent myocardial infarction or significant uncontrolled cardiovascular disease
- Uncontrolled glaucoma
- Significant ocular inflammatory disease
- Recent intraocular surgery within protocol-defined timeframe
- Active systemic infection
- Poorly controlled diabetes (e.g., HbA1c >8.5%)
- Participation in another investigational study within 3 months prior to screening
Where it is running
- Clinical Trial Site 1 — Beverly Hills, California, United States (enrolling)
- Clinical Trial Site 3 — Palo Alto, California, United States
- Clinical Trial Site 2 — Sacramento, California, United States
Full record on ClinicalTrials.gov
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